MAUDE Adverse Event Report: BAUSCH & LOMB BAUSCH & LOMB; LENS IMPLANT

Device Problems Difficult to Insert (1316); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

Patient underwent cataract procedure.Surgeon stated that haptic of lens was torn when he was inserting artificial lens.Tear of the base of the haptic which was partial tear which did not separate it from the rest of the optic.Lens implant centered and stable.

• Brand Name: BAUSCH & LOMB
• Type of Device: LENS IMPLANT
• Manufacturer (Section D): BAUSCH & LOMB
• MDR Report Key: 5327145
• MDR Text Key: 34437422
• Report Number: MW5058716
• Device Sequence Number: 1
• Product Code: HQL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR